Study of NP002 in Subjects With Idiopathic Parkinson's Disease to Treat Dyskinesias Due to Levodopa Therapy

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

October 31, 2009

Primary Completion Date

September 30, 2010

Study Completion Date

September 30, 2010

Conditions
Parkinson's Disease
Interventions
DRUG

nicotine

Oral capsule self administered in escalating doses from 1 mg to 6 mg, 4 times a day. Each dose is is taken for two weeks, except the highest dose, which is taken for 4 weeks. At the end of 10 weeks, the dose is tapered down over 9 days. Subject is continued on study through week 14.

OTHER

placebo comparator

oral capsules containing only excipient will be self-administered with the same regimen as the active drug, 4 times a day, approximately every 6 hours for 10 weeks and nine days. Study is continued through week 14.

Trial Locations (12)

11375

108-14 72nd Ave, Second floor, Forest Hills

11725

David L. Kreitzman, M.D., P.C., Commack

19107

Parkinson's Disease and Movement Center, Penn Comprehensive Neuroscience Center, Philadelphia

27705

Duke University Medical Center, Department of Neurology, Durham

33486

Parkinson's Disease & Movement Disorders Ctr of Boca Raton, Boca Raton

34102

Collier Neurologic Specialists, LLC, Naples

55427

Strurers Parkinson's Center, Golden Valley

74137

The Movement Disordedr Clinic of Oklahoma, Tusla

80113

Colorado Neurological Institute, Englewood

85013

Barrow Neurology Clinics at St. Joseph's Hospital and Medical Center, Phoenix

90033

Keck/USC School of Medicine -Department of Neurology, Los Angelis

93030

Pacific Neuroscience Medical Group, Oxnard

All Listed Sponsors
lead

Neuraltus Pharmaceuticals, Inc.

INDUSTRY